Multi-frame prosthetic heart valve

ABSTRACT

Described embodiments are directed toward prosthetic valves and systems and methods of making prosthetic valves. In accordance with an embodiment, a prosthetic valve comprises and leaflet frame, and outer frame and a film. The leaflet frame has a generally tubular shape defining a plurality of leaflet windows. The outer frame has a generally tubular shape. The leaflet frame is coaxially disposed at least partially within the outer frame. The leaflet frame and outer frame is coupled at least in part by a contiguous portion of the film. At least a portion of the contiguous portion of the film is contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween. The film defines a leaflet extending from each of the leaflet windows.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to provisional application Ser. No.61/739,721 filed Dec. 19, 2012, which is herein incorporated byreference in its entirety.

FIELD

The present disclosure relates generally to prosthetic valves and morespecifically synthetic flexible leaflet-type prosthetic valve devices,systems and methods.

BACKGROUND

Bioprosthetic valves have been developed that attempt to mimic thefunction and performance of a native valve. Flexible leaflets arefabricated from biological tissue such as bovine pericardium. In somevalve designs the biological tissue is sewn onto a relatively rigidframe that supports the leaflets and provides dimensional stability whenimplanted. Although bioprosthetic valves can provide excellenthemodynamic and biomechanical performance in the short term, they areprone to calcification and cusp tears, among other failure modes,requiring reoperation and replacement.

Attempts have been made to use synthetic materials, such aspolyurethane, among others, as a substitute for the biological tissue,to provide a more durable flexible leaflet prosthetic valve, hereinreferred to as a synthetic leaflet valve (SLV). However, syntheticleaflet valves have not become a valid valve replacement option sincethey suffer premature failure, due to, among other things, suboptimaldesign and lack of a durable synthetic material.

A number of fabrication techniques have been used to couple the leafletsto a frame, including sewing individual leaflets to the frame(biological and synthetic), and for synthetic leaflets only, injectionmolding and dip coating a polymer onto the frame. In many cases, theresulting leaflet is supported on the frame and defines a flap having amounting edge where the leaflet is coupled to the frame and a free edgethat allows the flap to move.

The leaflet moves under the influence of fluid pressure. In operation,the leaflets open when the upstream fluid pressure exceeds thedownstream fluid pressure and close when the downstream fluid pressureexceeds the upstream fluid pressure. The free edges of the leafletscoapt under the influence of downstream fluid pressure closing the valveto prevent downstream blood from flowing retrograde through the valve.

Valve durability under the repetitive loads of the leaflets opening andclosing is dependent, in part, on the load distribution between theleaflet and the frame. Further, substantial load is encountered on theleaflet when in the closed position. Mechanical failure of the leafletcan arise, for example, at the mounting edge, where the flexible leafletis supported by the relatively rigid frame. The repetitive loads ofleaflet opening and closing leads to material failure by fatigue, creepor other mechanism, depending in part on the leaflet material.Mechanical failure at the mounting edge is especially prevalent withsynthetic leaflets.

The durability of the valve leaflets is also, but not limited to, afunction of the character of bending by the leaflet during theopening-closing cycle. Small radius bends, creases and intersectingcreases, can produce high stress zones in the leaflet. These high stresszones can cause the formation of holes and tears under repetitiveloading.

Bioprosthetic valves may be delivered using surgical or transcathetertechniques. A surgical valve is implanted into a patient usingopen-heart surgical techniques. The surgical valve is usuallymanufactured to have a fixed diameter as opposed to a transcathetervalve which is required to attain a range of diameters for access anddelivery. The surgical valve is usually provided with a sewing cuffabout a perimeter of the valve to allow for suturing to the nativetissue orifice. Sewing cuffs are well known in the art.

A transcatheter prosthetic valve is delivered endovascularly via acatheter which can help to minimize patient trauma as compared with anopen-heart, surgical procedure. Open-heart surgery involves extensivetrauma to the patient, with attendant morbidity and extended recovery. Avalve delivered to the recipient site via a catheter avoids the traumaof open-heart surgery and may be performed on patients too ill or feebleto survive the open-heart surgery.

Some transcatheter valves comprise flexible leaflets mounted inside atubular metal frame. The metal frame may be self expanding orballoon-expanded from a pre-deployed compressed diameter to the deployedfunctional diameter. The diameter of the delivery system is dependent,in part, on the resulting thickness of the compressed valve leafletswithin the frame as it is mounted on the delivery catheter. In additionto the valve durability issues discussed above, the transcatheter valvemust also be able to withstand the handling and deployment stressesassociated with being compressed and expanded.

The transcatheter valve must be capable of being securely coupled to thetissue orifice of the implantation site after endovascular placement soas to avoid, for example, dislodgement or migration of the valve afterplacement. The coupling of the valve to the implantation site iscommonly facilitated by relatively high hoop strength of the frameplaced in urging engagement with the tissue orifice.

There exists a need for a durable prosthetic valve that may be deliveredeither surgically or endovascularly.

SUMMARY

Described embodiments are directed to an apparatus, system, and methodsfor valve replacement, such as cardiac valve replacement. Morespecifically, described embodiments are directed toward flexible leafletvalve devices and systems having a multi-part support member or frame,and methods of making and delivering the valve devices.

In accordance with an embodiment, a prosthetic valve comprises a leafletframe, an outer frame, and a film. The leaflet frame has a generallytubular shape defining a plurality of leaflet windows. The outer framehas a generally tubular shape. The leaflet frame is coaxially disposedat least partially within the outer frame. The leaflet frame and outerframe are coupled at least in part by a contiguous portion of the film.At least a portion of the contiguous portion of the film is containedbetween and coupling the leaflet frame and outer frame operable toprevent relative movement and contact therebetween. The film defines aleaflet extending from each of the leaflet windows.

In accordance with an embodiment, a prosthetic valve comprises andleaflet frame, and outer frame and a film. The leaflet frame has agenerally tubular shape defining a plurality of leaflet windows. Theouter frame has a generally tubular shape. The leaflet frame iscoaxially disposed at least partially within the outer frame. The outerframe includes frame elements that overlay the leaflet windows that aredefined by the leaflet frame in cooperative arrangement so as to providestructural support over the leaflet windows. The film defines a leafletextending from each of the leaflet windows.

In accordance with an embodiment, a method of making a prosthetic valve,comprises: wrapping a first layer of film into a tubular form about amandrel;

providing a leaflet frame having a generally tubular shape, the leafletframe having a leaflet frame leaflet surface and a leaflet frame outersurface, the leaflet frame defining a plurality of leaflet windowshaving a window top; providing an outer frame having a generally tubularshape, the outer frame having an outer frame leaflet surface and anouter frame outer surface; placing the leaflet frame and the outer frameover the first layer of film with the leaflet frame and outer framespaced apart from each other defining a bridge portion therebetween, theleaflet frame inner surface and the outer frame inner surface in contactwith the first layer of film;

forming a second layer of film over the leaflet frame and the outerframe in contact with the leaflet frame outer surface and the outerframe outer surface; coupling the first layer of film and the secondlayer of film to each other and to the leaflet frame and the outerframe; cutting the first layer of film and the second layer of filmacross the window top within the leaflet window so as to define aleaflet free edge; masking with release material a portion of the filmdisposed in the leaflet window that defines the leaflet to preventfurther bonding of the leaflet during subsequent processing steps;wrapping a third layer of film into a tubular form over the second layerof film and over the release material that is over the leaflet window,overlapping the leaflet frame, the outer frame, and over the bridgeportion between the leaflet frame and outer frame; coupling the thirdlayer of film and the second layer of film to each other;

removing the assembly from the mandrel; disposing coaxially and at leastpartially the leaflet frame into the outer frame, folding andoverlapping at least partially the bridge portion so as to contain thebridge portion between the leaflet frame and the outer frame; placingthe assembly back on the mandrel; coupling the bridge portion to itselfand to the third layer of film adjacent the leaflet frame outer surfaceand the first layer adjacent the outer frame inner surface in nestingengagement.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the present disclosure and are incorporated in andconstitute a part of this specification, illustrate embodimentsdescribed herein, and together with the description serve to explain theprinciples discussed in this disclosure.

FIG. 1A is a side view of an embodiment of a valve;

FIG. 1B is a side view of the embodiment of the valve of FIG. 1A;

FIG. 1C is a perspective view of the embodiment of the valve of FIG. 1A

FIG. 1D is a representation of a valve in an expanded configuration;

FIG. 1E is a representation of a valve in a compressed configuration;

FIG. 2A is a representation of the embodiment of the valve of FIG. 1Aunrolled to a flat orientation;

FIG. 2B is an exploded representation of the embodiment of the valve ofFIG. 1A unrolled to a flat orientation;

FIG. 3A is an axial or top view of the embodiment of the valve of FIG.1A in an open configuration;

FIG. 3B is an axial or top view of the embodiment of the valve of FIG.1A in a closed configuration;

FIG. 4A is a side view of an embodiment of a transcatheter deliverysystem within anatomy;

FIG. 4B is a side view of an embodiment of a surgical valve withinanatomy;

FIG. 5A is a cross-sectional view of an embodiment of the valve duringmanufacture;

FIG. 5B is a cross-sectional view of an embodiment of the valve;

FIG. 6A is a representation of an embodiment of an outer frame unrolledto a flat orientation;

FIG. 6B is a representation of an embodiment of an outer frame unrolledto a flat orientation;

FIG. 7A is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 7B is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 8A is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 8B is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 8C is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 8D is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 8E is a representation of an embodiment of a leaflet frame unrolledto a flat orientation;

FIG. 9A is a side view of valve components on an assembly mandrel, inaccordance with an embodiment;

FIG. 9B is a side view of valve components on an assembly mandrel, inaccordance with an embodiment;

FIG. 10A is a side exploded view of a prosthetic valve comprising aleaflet frame having a generally tubular shape and an outer frame havinga generally tubular shape that are coupled by a mechanic engagementmember, in accordance with another embodiment;

FIG. 10B is an assembled view of the embodiment of FIG. 10A;

FIG. 11A is a side view of an embodiment of a valve;

FIG. 11B is a perspective view of the embodiment of the valve of FIG.11A;

FIG. 12 is a side view of a leaflet frame on an assembly mandrel, inaccordance with an embodiment;

FIG. 13A is a side view of the leaflet frame on a cutting mandrel, inaccordance with an embodiment; and

FIG. 13B is a perspective view of the leaflet frame on the cuttingmandrel of FIG. 13A.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. Stateddifferently, other methods and apparatuses can be incorporated herein toperform the intended functions. It should also be noted that theaccompanying drawing figures referred to herein are not necessarilydrawn to scale, but may be exaggerated to illustrate various aspects ofthe present disclosure, and in that regard, the drawing figures shouldnot be construed as limiting.

Although the embodiments herein may be described in connection withvarious principles and beliefs, the described embodiments should not bebound by theory. For example, embodiments are described herein inconnection with prosthetic valves, more specifically cardiac prostheticvalves. However, embodiments within the scope of this disclosure can beapplied toward any valve or mechanism of similar structure and/orfunction. Furthermore, embodiments within the scope of this disclosurecan be applied in non-cardiac applications.

The term leaflet as used herein in the context of prosthetic valves is acomponent of a one-way valve wherein the leaflet is operable to movebetween an open and closed position under the influence of a pressuredifferential. In an open position, the leaflet allows blood to flowthrough the valve. In a closed position, the leaflet substantiallyblocks retrograde flow through the valve. In embodiments comprisingmultiple leaflets, each leaflet cooperates with at least one neighboringleaflet to block the retrograde flow of blood. The pressure differentialin the blood is caused, for example, by the contraction of a ventricleor atrium of the heart, such pressure differential typically resultingfrom a fluid pressure building up on one side of the leaflets whenclosed. As the pressure on an inflow side of the valve rises above thepressure on the outflow side of the valve, the leaflet opens and bloodflows therethrough. As blood flows through the valve into a neighboringchamber or blood vessel, the pressure on the inflow side equalizes withthe pressure on the outflow side. As the pressure on the outflow side ofthe valve raises above the blood pressure on the inflow side of thevalve, the leaflet returns to the closed position generally preventingretrograde flow of blood through the valve.

The term membrane as used herein refers to a sheet of materialcomprising a single composition, such as, but not limited to, expandedfluoropolymer.

The term composite material as used herein refers to a combination of amembrane, such as, but not limited to, expanded fluoropolymer, and anelastomer, such as, but not limited to, a fluoroelastomer. The elastomermay be imbibed within a porous structure of the membrane, coated on oneor both sides of the membrane, or a combination of coated on and imbibedwithin the membrane.

The term laminate as used herein refers to multiple layers of membrane,composite material, or other materials, such as elastomer, andcombinations thereof.

The term film as used herein generically refers to one or more of themembrane, composite material, or laminate.

The term biocompatible material as used herein generically refers to afilm or a biological material, such as, but not limited to, bovinepericardium.

The term leaflet window is defined as that space that a frame definesfrom which a leaflet extends. The leaflet may extend from frame elementsor adjacent to frame elements and spaced apart therefrom.

The terms native valve orifice and tissue orifice refer to an anatomicalstructure into which a prosthetic valve may be placed. Such anatomicalstructure includes, but is not limited to, a location wherein a cardiacvalve may or may not have been surgically removed. It is understood thatother anatomical structures that may receive a prosthetic valve include,but are not limited to, veins, arteries, ducts and shunts. Althoughreference is made herein to replacing a native valve with a prostheticvalve, it is understood and appreciated that a valve orifice or implantsite may also refer to a location in a synthetic or biological conduitthat may receive a valve for a particular purpose, and therefore thescope of the embodiments provided herein is not limited to valvereplacement.

As used herein, “couple” means to join, couple, connect, attach, adhere,affix, or bond, whether directly or indirectly, and whether permanentlyor temporarily.

Embodiments herein include various apparatus, systems, and methods for aprosthetic valve suitable for surgical and transcatheter placement, suchas, but not limited to, cardiac valve replacement. The valve is operableas a one-way valve wherein the valve defines a valve orifice into whichleaflets open to permit flow and close so as to occlude the valveorifice and prevent flow in response to differential fluid pressure.

Embodiments provided herein present an advancement in prosthetic valvetechnology related to, but not limited to, mechanical and biologicalperformance advantages. In accordance with some embodiments presentedherein, a prosthetic valve comprises two frames coupled together by acontiguous film in which a leaflet frame is nested into an outer framein a telescoping manner, wherein there is no chance for the valve toleak between the leaflet frame and the outer frame.

Commonly, a prosthetic flexible leaflet heart valve will have theleaflets attached directly to the frame by suturing. An alternate formof construction can have the leaflet material attached to the inside ofthe frame, but this arrangement presents the possibility of the leafletmaterial peeling away if not sufficiently bonded. Another form ofconstruction can have the leaflet material attached to the outside ofthe frame, but this arrangement often presents problems with abrasion ofthe leaflet on the frame. In the embodiments provided herein, theproblems are avoided by using a pair of frames, between which theleaflet material is contained. In accordance with embodiments providedherein, a pair of frames can be compressed and reexpanded whilemaintaining the original geometry of the frames with respect to oneanother, such to provide for transcatheter delivery.

In accordance with some embodiments presented herein, a prosthetic valvecomprises two frames; a leaflet frame and an outer frame. The film thatcomprises the leaflet may be coupled to the inner surface of the leafletframe. In some other embodiments, the film that comprises the leaflet iscontained between the leaflet frame and the outer frame and extendsthrough a leaflet window defined by the leaflet frame. The leaflet,therefore, is significantly prevented from peeling or delaminating as itis contained between the leaflet frame and outer frame, as compared towhere the leaflets are only coupled to the inner surface of the leafletframe.

In accordance with some embodiments presented herein, a prosthetic valvecomprises two frames; a leaflet frame and an outer frame. The leafletframe and the outer frame are separated from each other by a film. Inother words, there is a metal to polymer to metal interconnection,wherein there is no metal to metal contact between the two frames.

In accordance with some embodiments presented herein, a prosthetic valvecomprises two frames; a leaflet frame and an outer frame. The leafletframe is nested within the outer frame, wherein the leaflet frame andouter frame cooperate to provide relatively high resistance to flatplate compression, among other things. In accordance with someembodiments, the outer frame provides frame elements that overlay theleaflet windows that are defined by the leaflet frame so as to providestructural support over the leaflet windows. In accordance with someembodiments, the outer frame provides frame elements that overlay theleaflet windows that are defined by the leaflet frame so as to preventtissue from extending into the leaflet windows when implanted. Inaccordance with some embodiments, the outer frame provides frameelements that overlay the leaflet windows that are defined by theleaflet frame and act in concert so as to allow the frame assembly tocompress and expand uniformly for transcatheter embodiments.

In accordance with some embodiments presented herein, a prosthetic valvecomprises two frames; a leaflet frame and an outer frame. The leafletframe defines leaflet windows that define, in part, the shape of theleaflets. In some embodiments the leaflet comprises a flat base, whereinthe leaflet bends from the base towards the leaflet free edge withminimal creasing and fluttering. In some embodiments the leafletcomprises a flat base, that, among other things, provides for one ormore of a shorter valve length, substantially prevents blood stagnationand pooling and encourages washing at the base, as compared to leafletshaving a rounded base.

In accordance with some embodiments presented herein, a prosthetic valvecomprises two frames; a leaflet frame and an outer frame. The leafletframe defines leaflet windows from which the leaflets extend. Theleaflets are defined by the intersection of films that form anoverlapping zone so as to define, at least in part, the leaflet baseand/or the leaflet sides.

The Valve

FIG. 1A is a side view of a valve 100, in accordance with an embodiment.FIG. 1B is also a side view of the valve 100 of FIG. 1A rotated 60degrees about the longitudinal axis X. FIG. 1C is a perspective view ofthe valve 100 of FIG. 1A. FIG. 2A is a side view of the valve 100 ofFIG. 1A, wherein the valve 100 has been longitudinally cut and laid opento better illustrate the elements of the generally tubular-shaped valve100. FIG. 2B is an exploded view of the embodiment of FIG. 2A. FIGS. 3Aand 3B are axial views of the valve 100 of FIG. 1A in an open and closedconfiguration, respectively. In FIG. 3B the leaflets 140 are shownslightly open to better show the features but it is understood that afully closed valve 100 will have the free edges 142 of the leaflets 140coming together to coapt under the influence of downstream fluidpressure which results in closing the valve to prevent downstream bloodfrom flowing retrograde through the valve.

The valve 100 comprises an outer frame 120, a leaflet frame 130, and afilm 160 covering the outer frame 120 and leaflet frame 130, couplingthe outer frame 120 to the leaflet frame 130, and defining leaflets 140.The embodiment of valve 100 is discussed further related to atranscatheter valve that may be compressed and re-expanded. It isunderstood that the embodiment of valve 100 is also applicable to asurgical valve by the addition of a sewing cuff 170, as shown in FIG.4B. Leaflet frame and outer frame configurations related to surgicalvalve only embodiments where the valves have a fixed diameter, will bediscussed in other embodiments later in this disclosure.

In accordance with an embodiment, a prosthetic valve comprises a leafletframe 130 having a generally tubular shape, an outer frame 120 having agenerally tubular shape, and film 160. The leaflet frame 130 iscoaxially disposed at least partially within the outer frame 120. Theouter frame 120 provides frame elements that overlay leaflet windowsthat are defined by the leaflet frame 130 so as to provide structuralsupport over the leaflet windows, as shown in FIGS. 1A-1B. The leafletframe 130 defines a plurality of leaflet windows, wherein the film 160defines a leaflet extending from each of the leaflet windows.

The Outer Frame

The outer frame 120 is a generally tubular member defining a generallyopen pattern of apertures 122, in accordance with an embodiment. Inaccordance with transcatheter embodiments, the outer frame 120 isoperable to allow the outer frame 120 to be compressed and expandedbetween different diameters. The outer frame 120 comprises an outerframe first end 121 a and an outer frame second end 121 b opposite theouter frame first end 121 a. The outer frame 120 comprises an outerframe outer surface 126 a and an outer frame inner surface 126 bopposite the outer frame outer surface 126 a, as shown in FIG. 5A. Theouter frame 120 may comprise a structure known in the art as a stent. Astent is a tubular member that may have a small diameter suitable forpercutaneous transcatheter delivery into the anatomy, and may beexpanded to a larger diameter when deployed into the anatomy. Stentshaving various designs and material properties are well known in theart.

By way of example, and as illustrated in the embodiments of FIGS. 1A-1Cand 2A-2B, the valve 100 includes the outer frame 120 that defines astent having apertures 122 having generally a diamond shape when in alarge diameter configuration, as shown generally in FIG. 1D. Uponcompression to a smaller diameter, the apertures 122 deform to generallydefine an elongated diamond shape, as shown generally in FIG. 1E. Uponre-expansion to a larger diameter, the apertures 122 re-expand to againdefine a generally diamond shape.

FIGS. 6A and 6B are side views of alternative embodiments of the outerframe 120 a, 120 b wherein the outer frame has been longitudinally cutand laid open to better illustrate the elements of the outer frame. Itis appreciated that there are many embodiments of the outer frame havingconfigurations suitable for the particular purpose.

An open framework of the stent can define any number of features,repeatable or otherwise, such as geometric shapes and/or linear ormeandering series of sinusoids. Geometric shapes can comprise any shapethat facilitates substantially uniform circumferential compression andexpansion. The outer frame 120 may comprise a cut tube, or any otherelement suitable for the particular purpose. The outer frame 120 may beetched, cut, laser cut, or stamped into a tube or a sheet of material,with the sheet then formed into a substantially cylindrical structure.Alternatively, an elongated material, such as a wire, bendable strip, ora series thereof, can be bent or braided and formed into a substantiallycylindrical structure wherein the walls of the cylinder comprise an openframework that is compressible to a smaller diameter in a generallyuniform and circumferential manner and expandable to a larger diameter.

It is known that stents of various designs may be elastically deformableso as to be self-expanding under spring loads. It is also known thatstents of various designs may be plastically deformable so as to bemechanically expanded such as with a balloon. It is also known thatstents of various designs may be plastically deformable as well aselastically deformable. The embodiments of the outer frame 120 presentedherein are not to be limited to a specific stent design or mode ofexpansion.

The outer frame 120 can comprise any metallic or polymeric biocompatiblematerial. For example, the outer frame 120 can comprise a material, suchas, but not limited to nitinol, cobalt-nickel alloy, stainless steel, orpolypropylene, acetyl homopolymer, acetyl copolymer, ePTFE, other alloysor polymers, or any other biocompatible material having adequatephysical and mechanical properties to function as described herein.

In accordance with embodiments, the outer frame 120 and/or leaflet frame130 can be configured to provide positive engagement with an implantsite to firmly anchor the valve 100 to the site, as shown in FIG. 4Arepresenting a transcatheter deployment of the valve 100. In accordancewith an embodiment, the outer frame 120 can comprise a sufficientlyrigid frame having small elastic recoil so as to maintain sufficientapposition against a tissue orifice 150 to maintain position. Inaccordance with another embodiment, the outer frame 120 and/or leafletframe 130 can be configured to expand to a diameter that is larger thana tissue orifice 150 so that when valve 100 expands into the tissueorifice 150, it can be firmly seated therein. In accordance with anotherembodiment, the outer frame 120 can comprise one or more anchors (notshown) configured to engage the implant site, such as a tissue orifice150, to secure the valve 100 to the implant site.

It is appreciated that other elements or means for coupling the valve100 to an implant site are anticipated. By way of example, but notlimited thereto, other means, such as mechanical and adhesive means maybe used to couple the valve 100 to a synthetic or biological conduit.

Leaflet Frame

Referring again to FIGS. 1C and 2B, the leaflet frame 130 is a generallytubular member defining a plurality of leaflet windows 137 coupledtogether by connecting elements 139, in accordance with an embodiment.The leaflet frame 130 comprises a leaflet frame first end 138 a and aleaflet frame second end 138 b opposite the leaflet frame first end 138a. The leaflet frame 130 comprises a leaflet frame outer surface 132 aand a leaflet frame inner surface 132 b opposite the leaflet frame outersurface 132 a, as shown in FIG. 5A. The leaflet frame first end 138 aand the leaflet frame second end 138 b define a generally zigzagconfiguration to facilitate flexion about flex points 136 such as whichfacilitates compression and expansion between different diameters forcompression onto a delivery device and expansion by a balloon for thetranscatheter valve 100 embodiments, as generally explained for theouter frame 120. As will be discussed later, the surgical valve 100embodiment may or may not have the zigzag configuration since thesurgical valve 100 may be of a fixed diameter and need not be operableto compress and re-expand.

The leaflet frame 130 may be referred to in a general sense as a stentor a frame.

The leaflet frame 130 defines a predetermined repeating pattern as shownin FIG. 2B, in accordance with an embodiment. The leaflet frame 130defines three interconnected leaflet windows 137 having a substantiallytriangular shape. Each of the leaflet windows 137 includes two leafletwindow sides 133 including posts 133, a leaflet window base 134, and aleaflet window top 135. In this embodiment, the leaflet window base 134defines a flex point 136 which will be described further below. Aleaflet window side 133 and leaflet window top 135 of one leaflet window137 is interconnected with a leaflet window side 133 of an adjacentleaflet window 137 at the posts 131.

The leaflet frame 130 defines any number of features and geometricshapes that facilitate substantially uniform circumferential compressionand expansion. The leaflet frame 130 may comprise a cut tube, or anyother element suitable for the particular purpose. The leaflet frame 130may be etched, cut, laser cut, or stamped into a tube or a sheet ofmaterial, with the sheet then formed into a substantially cylindricalstructure. Alternatively, an elongated material, such as a wire,bendable strip, or a series thereof, can be bent or braided and formedinto a substantially cylindrical structure wherein the walls of thecylinder comprise an open framework that is compressible to a smallerdiameter in a generally uniform and circumferential manner andexpandable to a larger diameter.

The leaflet frame 130 can comprise any metallic or polymericbiocompatible material. For example, the leaflet frame 130 can comprisea material, such as, but not limited to nitinol, cobalt-nickel alloy,stainless steel, or polypropylene, acetyl homopolymer, acetyl copolymer,ePTFE, other alloys or polymers, or any other biocompatible materialhaving adequate physical and mechanical properties to function asdescribed herein.

As will be described in more detail below, a film 160 is disposed overeach of the three leaflet windows 137 to form a leaflet 140. Furtherembodiments will be described below wherein the leaflet window 137defines shapes other than a substantially triangular shape, including,but not limited to a parabolic shape and a trapezoidal shape, with andwithout a leaflet window top 135, suitable for a particular purpose ofan embodiment of a surgical and transcatheter valve 100.

FIGS. 7A and 7B are side views of alternative embodiments of the leafletframe 130 a, 130 b wherein the leaflet frame has been longitudinally cutand laid open to better illustrate the elements of the leaflet frame.The leaflet frame 130 a includes leaflet windows 137 a having asubstantially triangular shape defining a pointed leaflet window base134 a. The leaflet frame 130 b includes leaflet windows 137 b having asubstantially triangular shape defining a flat leaflet window base 134b. The flat leaflet window base 134 b may be used to define the leafletbase.

FIGS. 8A-8C are side views of alternative embodiments of the leafletframe 130 c-130 e wherein the leaflet frame has been longitudinally cutand laid open to better illustrate the elements of the leaflet frame.The leaflet frame 130 c includes leaflet windows 137 c having asubstantially triangular shape defining a pointed leaflet window base134 c. The leaflet frame 130 d includes leaflet windows 137 d having asubstantially parabolic shape defining a rounded leaflet window base 134d. The flat leaflet window base 134 b may be used to define the leafletbase. The leaflet frame 130 e includes leaflet windows 137 e having asubstantially triangular shape defining a pointed leaflet window base134 e but not having a leaflet window top.

FIG. 8D is a side view of an alternative embodiment of the leaflet frame130 f wherein the leaflet frame 130 f has been longitudinally cut andlaid open to better illustrate the elements of the leaflet frame 130 f.A leaflet 140 f is shown in dotted line to represent where the leaflet143 f is located within the leaflet window 137 f, the leaflet window 137f being defined by the leaflet window sides 133 f and the leaflet windowbase 134 f. The two leaflet sides 141 f diverge from the leaflet base143 f, wherein the leaflet base 143 f is substantially flat, as shown indashed lines in FIG. 8D. The leaflet frame 130 f further defines posts1121 from which the leaflet free edge 142 f extends.

FIG. 8E is a side view of an alternative embodiment of the leaflet frame130 g wherein the leaflet frame 130 g has been longitudinally cut andlaid open to better illustrate the elements of the leaflet frame 130 g.A leaflet 140 g is shown in dotted line to represent where the leaflet143 g is located within the leaflet window 137 g, the leaflet window 137g being defined by the leaflet window sides 133 g and the leaflet windowbase 134 g. Two leaflet sides 141 g diverge from the leaflet base 143 g,wherein the leaflet base 143 g is substantially flat.

As previously discussed, the leaflet window base may be used to definethe leaflet base in accordance with embodiments. Also as previouslydiscussed, the leaflet base may be defined as a virtual leaflet base 143by a fold in the film 160 in the fold region spaced apart from theleaflet window base, as shown in FIG. 1B. It is appreciated that thereare many embodiments of the outer frame having configurations suitablefor the particular purpose.

In transcatheter valve 100 embodiments, the leaflet frame 130 iselastically, plastically, or both, compressible to obtain a relativelysmall diameter to accommodate percutaneous transcatheter mounting anddelivery. In accordance with an embodiment as shown in FIG. 2B, theleaflet frame 130 may comprise one or more flex points 136 so as toprovide a preferential flexing location for the leaflet frame 130 toflex when compressed to a smaller diameter. A flex point 136 comprises asite on the leaflet frame 130 that undergoes the highest degree ofbending when transitioning from an expanded state to collapsed state andvice versa. The flex point 136 can comprise a geometry, structuralmodification or material modification, among others, that biases theleaflet frame 130 to bend at the flex point 136 when compressed.

The leaflet frame 130 may comprise, such as, but not limited to, anyelastically deformable metallic or polymeric biocompatible material, inaccordance with embodiments. The leaflet frame 130 may comprise ashape-memory material, such as nitinol, a nickel-titanium alloy. Othermaterials suitable for the leaflet frame 130 include, but are notlimited to, other titanium alloys, stainless steel, cobalt-nickel alloy,polypropylene, acetyl homopolymer, acetyl copolymer, other alloys orpolymers, or any other biocompatible material having adequate physicaland mechanical properties to function as a leaflet frame 130 asdescribed herein.

In accordance with an embodiment, the leaflet frame 130 and the outerframe 120 comprise a shape memory material operable to flex under loadand retain its original shape when the load is removed, thus allowingthe leaflet frame 130 and the outer frame 120 to self-expand from acompressed shape to a predetermined shape. The leaflet frame 130 and theouter frame 120 may comprise the same or different materials. Inaccordance with an embodiment, the leaflet frame 130 and the outer frame120 are plastically deformable to be expanded by a balloon. In anotherembodiment the outer frame 120 and the leaflet frame 130 are elasticallydeformable so as to be self-expanding.

The Film

The film 160 is generally any sheet-like material that is biologicallycompatible and configured to couple to the outer frame 120 and theleaflet frame 130, in accordance with embodiments. It is understood thatthe term “film” is used generically for one or more biocompatiblematerials suitable for a particular purpose. The leaflets 140 are alsocomprised of the film 160.

In accordance with an embodiment, the biocompatible material is a film160 that is not of a biological source and that is sufficiently flexibleand strong for the particular purpose, such as a biocompatible polymer.In an embodiment, the film 160 comprises a biocompatible polymer that iscombined with an elastomer, referred to as a composite.

It is also understood that the film 160 coupled to the outer frame 120may not be the same film 160 coupled to the leaflet frame 130, inaccordance with embodiments. Details of various types of film 160 arediscussed below. In an embodiment, the film 160 may be formed from agenerally tubular material to at least partially cover the outer frame120 and the leaflet frame 130. The film 160 can comprise one or more ofa membrane, composite material, or laminate. Details of various types offilm 160 are discussed below.

Leaflet

Each leaflet window 137 is provided with a biocompatible material, suchas a film 160, which is coupled to a portion of the leaflet window sides133 with the film 160 defining a leaflet 140. Each leaflet 140 defines aleaflet free edge 142 and a leaflet base 143, in accordance with anembodiment. As will be described below, it is anticipated that aplurality of embodiments of leaflet base configurations may be provided.In accordance with an embodiment, the film 160 is coupled to a portionof the leaflet window sides 133 and to the leaflet window base 134 wherethe leaflet 140 is defined by the portion of the leaflet window sides133 and to the leaflet window base 134. In accordance with anotherembodiment, the film 160 is coupled to a portion of the leaflet windowsides 133 but not the leaflet window base 134 of the leaflet frame 130where the leaflet 140 is defined by the portion of the leaflet windowsides 133 and to a virtual leaflet base 143 a defined in a fold regionas will be described below.

The shape of the leaflets 140 are defined in part by the shape of theleaflet window 137 and the leaflet free edge 142. As will be discussedbelow in accordance with an embodiment, the shape of the leaflets 140also depends in part on a process that induces a fold at the fold line145 to define a virtual leaflet base 143 a as will be described furtherbelow, so as to impart a predetermined shape to the leaflet 140. Sincehigh bending stresses are located at the leaflet base, defining avirtual leaflet base 143 a that is not bound by the leaflet window base134 may reduce the chance of tearing of the leaflet 140 at the leafletbase 143—leaflet window base 134 interface. It may also reduce bloodpooling and stagnation at the leaflet base as compared with a roundedleaflet base.

In accordance with an embodiment, substantially the entire leaflet frame130 lies adjacent to the outer frame inner surface 129, as shown in FIG.3A. As such, when the leaflets 140 are in a fully open position, thevalve 100 presents a substantially circular valve orifice 102 as shownin FIG. 3A. Fluid flow is permitted through the valve orifice 102 whenthe leaflets 140 are in an open position.

As the leaflets 140 cycle between the open and closed positions, theleaflets 140 generally flex about the leaflet base 143 and the portionof the leaflet window sides 133 to which the leaflet are coupled. Whenthe valve 100 is closed, generally about half of each leaflet free edge142 abuts an adjacent half of a leaflet free edge 142 of an adjacentleaflet 140, as shown in FIG. 3B. The three leaflets 140 of theembodiment of FIG. 3B meet at a triple point 148. The valve orifice 102is occluded when the leaflets 140 are in the closed position stoppingfluid flow.

Referring to FIG. 3B, in accordance with an embodiment, each leaflet 140includes a central region 182 and two side regions 184 on opposite sidesof the central region 182 The two central region sides 183 converge fromthe leaflet base 143 to the free edge 142. Each of the side regions 184have a shape substantially that of a triangle and each are defined byone of the central region sides 183, one of the leaflet sides 141, andthe free edge 142.

The leaflet 140 can be configured to actuate at a pressure differentialin the blood caused, for example, by the contraction of a ventricle oratrium of the heart, such pressure differential typically resulting froma fluid pressure building up on one side of the valve 100 when closed.As the pressure on an inflow side of the valve 100 rises above thepressure on the outflow side of the valve 100, the leaflet 140 opens andblood flows therethrough. As blood flows through the valve 100 into aneighboring chamber or blood vessel, the pressure equalizes. As thepressure on the outflow side of the valve 100 rises above the bloodpressure on the inflow side of the valve 100, the leaflet 140 returns tothe closed position generally preventing the retrograde flow of bloodthrough the inflow side of the valve 100.

It is understood that the leaflet frame 130 may comprise any number ofleaflet windows 137, and thus leaflets 140, suitable for a particularpurpose, in accordance with embodiments. Leaflet frames 130 comprisingone, two, three or more leaflet windows 137 and corresponding leaflets140 are anticipated.

Valve Film

As shown in the exploded unwrapped view of FIG. 2B of the embodiment ofFIG. 2A, the outer frame 120 is located substantially coplanar,laterally adjacent to and spaced apart from the leaflet frame 130. Theleaflet window base 134 of the leaflet window 137 is located proximateto an outer frame first end 121 a of the outer frame 120 with theleaflet frame first end 138 a of the leaflet frame 130 extending awayfrom the outer frame 120. This placement is also used in the manufactureof the valve 100 as will be discussed below. While in this placement,the film 160 is coupled to the outer frame 120 and a portion of theleaflet frame 130 which couples the outer frame 120 to the leaflet frame130.

The film 160 that spans the space between the outer frame 120 and theleaflet frame 130 defines at least in part a fold region 144. As will bediscussed further below, in accordance with an embodiment, the foldregion 144 is provided to allow the leaflet frame 130 to betelescopically disposed within the outer frame 120, the outer frame 120having an inner diameter that is larger than the outer diameter of theleaflet frame 130, in accordance with an embodiment of a method ofmaking the valve 100, hence creating a fold within the fold region 144along a generally circumferential line 146.

It is anticipated that the film 160 may be coupled to the leaflet frame130 and the outer frame 120 in many ways suitable for a particularpurpose, in accordance with embodiments. In accordance with anembodiment, the outer frame 120 may be wrapped with overlapping layersof a film 160 having a first composition. The leaflet frame 130 may bewrapped with overlapping layers of a film 160 having a secondcomposition. The wrapped leaflet frame 130, the wrapped outer frame 120,and the space between the outer frame 120 and the leaflet frame 130 maybe wrapped with overlapping layers of a film 160 having a thirdcomposition defining, at least in part, the fold region 144.

In another embodiment, the film 160 may be coupled to the inner or outersurface of the leaflet frame 130 and outer frame 120. In anotherembodiment, the film 160 may be coupled to the inner and outer surfaceof the leaflet frame 130 and outer frame 120 sandwiching the leafletframe 130 and outer frame 120 between the film 160. As will be discussedbelow, coupling the film 160 to at least the leaflet frame outer surface132 a and the outer frame inner surface 126 b, as shown in FIGS. 5A-5Bmay provide additional support to the leaflet 140 to preventdisengagement of the leaflet 140 from the leaflet frame 130 since aportion of the film 160 is contained between the leaflet frame 130 andthe outer frame 120, as shown in FIG. 5B.

Wherever the film 160 is present it prevents blood from travelingthrough or across the valve 100 other than through the valve orifice 102when the leaflets 140 are in an open position and uncovered portions ofthe leaflet frame 130 or outer frame 120. As such, the film 160 createsa barrier to blood flow in any interstitial space(s) or apertures 122 ofthe outer frame 120 and leaflet frame 130, and therebetween, that thefilm 160 covers.

The film 160 is fixedly secured or otherwise coupled at a single or aplurality of locations of the inner surface or outer surface of theouter frame 120 and leaflet frame 130, for example, using one or more oftaping, heat shrinking, adhesion and other processes known in the art.In some embodiments, a plurality of membrane/composite layers, i.e., alaminate, are used and can be coupled to both the inner and outersurfaces of the outer frame 120 and the leaflet frame 130 to form atleast a portion of the film 160.

The film 160 comprises any material(s) that have the suitable physicaland mechanical properties to perform the functions described herein. Thefilm 160 may comprise the same material that the leaflet 140 comprises,as described above, or a different material. Similarly, the film 160 mayor may not be homogenous in material composition. Different portions ofthe film 160 can comprise different materials which can give itdifferent physical and mechanical properties.

As previously discussed, in an embodiment of a method of making thevalve 100, the leaflet frame 130 is disposed within the outer frame 120in a telescoping manner whereby folding the film 160 in the fold region144, as shown in FIGS. 5A-5B. The leaflet frame 130 is therefore nestedwithin the outer frame 120 while remaining coaxial therewith. Theassembly is further processed to couple the fold region 144 to itselfand to the wrapped leaflet frame 130 and outer frame 120 whilepreventing the film 160 defining the leaflets 140 from adhering tounintended parts of the valve 100 that would prevent leaflet function.

In accordance with another embodiment, the frame members defining theapertures of the leaflet frame 130 and outer frame 120 arepreferentially aligned to provide overlapping and complimentaryarrangement so as to proved structural rigidity to the assembly.

In accordance with an embodiment of a transcatheter valve 100, withreference to FIGS. 1D-1E, the valve 100 may be compressed into acollapsed configuration having a smaller diameter and expanded into anexpanded configuration so that the valve 100 can be endovascularlydelivered in the collapsed configuration and expanded upon deploymentwithin the tissue orifice 150 as shown in FIG. 4A. The leaflet frame 130and the outer frame 120 can be operable to recover circumferentialuniformity when transitioning from the collapsed configuration to theexpanded configuration.

The valve 100 may be mounted onto a delivery catheter, suitable for aparticular purpose. The diameter of the valve 100 in the collapsedconfiguration is determined in part by the thickness of the leafletframe 130 within the outer frame 120 and the leaflet thickness.

Leaflet Film

The biocompatible material that makes up the leaflet 140 can compriseany biological tissue or synthetic, biocompatible materials sufficientlycompliant and flexible, such as a biocompatible polymer. In anembodiment, the leaflet 140 comprises a biocompatible polymer that iscombined with an elastomer, referred to as a composite. A materialaccording to one embodiment includes a composite material comprising anexpanded fluoropolymer membrane, which comprises a plurality of spaceswithin a matrix of fibrils, and an elastomeric material. It should beappreciated that multiple types of fluoropolymer membranes and multipletypes of elastomeric materials can be combined to form a laminate whileremaining within the scope of the present disclosure. It should also beappreciated that the elastomeric material can include multipleelastomers, multiple types of non-elastomeric components, such asinorganic fillers, therapeutic agents, radiopaque markers, and the likewhile remaining within the scope of the present disclosure.

In accordance with an embodiment, the composite material includes anexpanded fluoropolymer material made from porous ePTFE membrane, forinstance as generally described in U.S. Pat. No. 7,306,729 to Bacino.

The expandable fluoropolymer, used to form the expanded fluoropolymermaterial described, may comprise PTFE homopolymer. In alternativeembodiments, blends of PTFE, expandable modified PTFE and/or expandedcopolymers of PTFE may be used. Non-limiting examples of suitablefluoropolymer materials are described in, for example, U.S. Pat. No.5,708,044, to Branca, U.S. Pat. No. 6,541,589, to Baillie, U.S. Pat. No.7,531,611, to Sabol et al., U.S. patent application Ser. No. 11/906,877,to Ford, and U.S. patent application Ser. No. 12/410,050, to Xu et al.

The expanded fluoropolymer membrane can comprise any suitablemicrostructure for achieving the desired leaflet performance. Inaccordance with an embodiment, the expanded fluoropolymer comprises amicrostructure of nodes interconnected by fibrils, such as described inU.S. Pat. No. 3,953,566 to Gore. The fibrils radially extend from thenodes in a plurality of directions, and the membrane has a generallyhomogeneous structure. Membranes having this microstructure maytypically exhibit a ratio of matrix tensile strength in two orthogonaldirections of less than 2, and possibly less than 1.5.

In another embodiment, the expanded fluoropolymer membrane has amicrostructure of substantially only fibrils, as is generally taught byU.S. Pat. No. 7,306,729, to Bacino. The expanded fluoropolymer membranehaving substantially only fibrils, can possess a high surface area, suchas greater than 20 m²/g, or greater than 25 m²/g, and in someembodiments can provide a highly balanced strength material having aproduct of matrix tensile strengths in two orthogonal directions of atleast 1.5×10⁵ MPa², and/or a ratio of matrix tensile strengths in twoorthogonal directions of less than 4, and possibly less than 1.5.

The expanded fluoropolymer membrane can be tailored to have any suitablethickness and mass to achieve the desired leaflet performance. By way ofexample, but not limited thereto, the leaflet 140 comprises an expandedfluoropolymer membrane having a thickness of about 0.1 μm. The expandedfluoropolymer membrane can possess a mass per area of about 1.15 g/m².Membranes according to an embodiment of the invention can have matrixtensile strengths of about 411 MPa in the longitudinal direction and 315MPa in the transverse direction.

Additional materials may be incorporated into the pores or within thematerial of the membranes or in between layers of membranes to enhancedesired properties of the leaflet. Composite materials described hereincan be tailored to have any suitable thickness and mass to achieve thedesired leaflet performance. Composite materials according toembodiments can include fluoropolymer membranes and have a thickness ofabout 1.9 μm and a mass per area of about 4.1 g/m².

The expanded fluoropolymer membrane combined with elastomer to form acomposite material provides the elements of the present disclosure withthe performance attributes required for use in high-cycle flexuralimplant applications, such as heart valve leaflets, in various ways. Forexample, the addition of the elastomer can improve the fatigueperformance of the leaflet by eliminating or reducing the stiffeningobserved with ePTFE-only materials. In addition, it may reduce thelikelihood that the material will undergo permanent set deformation,such as wrinkling or creasing, that could result in compromisedperformance. In one embodiment, the elastomer occupies substantially allof the pore volume or space within the porous structure of the expandedfluoropolymer membrane. In another embodiment the elastomer is presentin substantially all of the pores of the at least one fluoropolymerlayer. Having elastomer filling the pore volume or present insubstantially all of the pores reduces the space in which foreignmaterials can be undesirably incorporated into the composite. An exampleof such foreign material is calcium that may be drawn into the membranefrom contact with the blood. If calcium becomes incorporated into thecomposite material, as used in a heart valve leaflet, for example,mechanical damage can occur during cycling open and closed, thus leadingto the formation of holes in the leaflet and degradation inhemodynamics.

In an embodiment, the elastomer that is combined with the ePTFE is athermoplastic copolymer of tetrafluoroethylene (TFE) and perfluoromethylvinyl ether (PMVE), such as described in U.S. Pat. No. 7,462,675 toChang et al. As discussed above, the elastomer is combined with theexpanded fluoropolymer membrane such that the elastomer occupiessubstantially all of the void space or pores within the expandedfluoropolymer membrane to form a composite material. This filling of thepores of the expanded fluoropolymer membrane with elastomer can beperformed by a variety of methods. In one embodiment, a method offilling the pores of the expanded fluoropolymer membrane includes thesteps of dissolving the elastomer in a solvent suitable to create asolution with a viscosity and surface tension that is appropriate topartially or fully flow into the pores of the expanded fluoropolymermembrane and allow the solvent to evaporate, leaving the filler behind.

In one embodiment, the composite material comprises three layers: twoouter layers of ePTFE and an inner layer of a fluoroelastomer disposedtherebetween. Additional fluoroelastomers can be suitable and aredescribed in U.S. Publication No. 2004/0024448 to Chang.

In another embodiment, a method of filling the pores of the expandedfluoropolymer membrane includes the steps of delivering the filler via adispersion to partially or fully fill the pores of the expandedfluoropolymer membrane.

In another embodiment, a method of filling the pores of the expandedfluoropolymer membrane includes the steps of bringing the porousexpanded fluoropolymer membrane into contact with a sheet of theelastomer under conditions of heat and/or pressure that allow elastomerto flow into the pores of the expanded fluoropolymer membrane.

In another embodiment, a method of filling the pores of the expandedfluoropolymer membrane includes the steps of polymerizing the elastomerwithin the pores of the expanded fluoropolymer membrane by first fillingthe pores with a prepolymer of the elastomer and then at least partiallycuring the elastomer.

After reaching a minimum percent by weight of elastomer, the leafletsconstructed from fluoropolymer materials or ePTFE generally performedbetter with increasing percentages of elastomer resulting insignificantly increased cycle lives. In one embodiment, the elastomercombined with the ePTFE is a thermoplastic copolymer oftetrafluoroethylene and perfluoromethyl vinyl ether, such as describedin U.S. Pat. No. 7,462,675 to Chang et al., and other references thatwould be known to those of skill in the art. Other biocompatiblepolymers which can be suitable for use in leaflet 140 include but arenot limited to the groups of urethanes, silicones(organopolysiloxanes),copolymers of silicon-urethane, styrene/isobutylene copolymers,polyisobutylene, polyethylene-co-polyvinyl acetate), polyestercopolymers, nylon copolymers, fluorinated hydrocarbon polymers andcopolymers or mixtures of each of the foregoing.

Other Considerations

FIGS. 10A and 10B are side exploded and assembled views, respectively,of a prosthetic valve 1000 comprising a leaflet frame 1130 having agenerally tubular shape and an outer frame 1120 having a generallytubular shape that are coupled by a mechanic engagement member 1110, inaccordance with another embodiment. The leaflet frame 1130 comprises anengagement member 1110 operable to engage the outer frame 1130 to affectcoupling in which the leaflet frame 1130 is nested into the outer frame1120 in a telescoping manner. The leaflet frame 1130 defines a pluralityof leaflet windows 137, wherein film defines a leaflet extending fromeach of the leaflet windows 137.

In accordance with an embodiment, the valve 100 can be configured toprevent interference with a heart conduction system by not covering abundle branch in the left ventricle when implanted, such as might beencountered with an aortic valve replacement procedure. For example, thevalve 100 can comprise a length of less than about 25 mm or less thanabout 18 mm. The valve 100 can also comprise an aspect ratio of lessthan one, wherein the ratio describes the relationship between thelength of the valve 100 to the expanded, functional diameter. However,the valve 100 can be constructed at any length and, more generally, anydesirable dimension.

In a transcatheter embodiment, in a collapsed state, the valve 100 canhave a collapsed profile that is less than about 35% of the expandedprofile. For example, the valve 100 comprising a 26 mm expanded diametercan have a collapsed diameter of less than about 8 mm, or less thanabout 6 mm. The percent difference in diameter is dependent ondimensions and materials of the valve 100 and its various applications,and therefore, the actual percent difference is not limited by thisdisclosure.

The valve 100 can further comprise a bio-active agent. Bio-active agentscan be coated onto a portion or the entirety of the film 160 forcontrolled release of the agents once the valve 100 is implanted. Thebio-active agents can include, but are not limited to, vasodilator,anti-coagulants, anti-platelet, anti-thrombogenic agents such as, butnot limited to, heparin. Other bio-active agents can also include, butare not limited to agents such as, for example,anti-proliferative/antimitotic agents including natural products such asvinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine),paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide),antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin andidarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin(mithramycin) and mitomycin, enzymes (L-asparaginase which systemicallymetabolizes L-asparagine and deprives cells which do not have thecapacity to synthesize their own asparagine); antiplatelet agents suchas G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists;anti-proliferative/antimitotic alkylating agents such as nitrogenmustards (mechlorethamine, cyclophosphamide and analogs, melphalan,chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine andthiotepa), alkyl sulfonates-busulfan, nitrosoureas (carmustine (BCNU)and analogs, streptozocin), trazenes-dacarbazinine (DTIC);anti-proliferative/antimitotic antimetabolites such as folic acidanalogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine,and cytarabine), purine analogs and related inhibitors (mercaptopurine,thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine});platinum coordination complexes (cisplatin, carboplatin), procarbazine,hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen);anti-coagulants (heparin, synthetic heparin salts and other inhibitorsof thrombin); fibrinolytic agents (such as tissue plasminogen activator,streptokinase and urokinase), aspirin, dipyridamole, ticlopidine,clopidogrel, abciximab; antimigratory; antisecretory (breveldin);anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone,fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone,triamcinolone, betamethasone, and dexamethasone), non-steroidal agents(salicylic acid derivatives i.e. aspirin; para-aminophenol derivativesi.e. acetominophen; indole and indene acetic acids (indomethacin,sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac,and ketorolac), arylpropionic acids (ibuprofen and derivatives),anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids(piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone),nabumetone, gold compounds (auranofin, aurothioglucose, gold sodiumthiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-506),sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenicagents: vascular endothelial growth factor (VEGF), fibroblast growthfactor (FGF); angiotensin receptor blockers; nitric oxide donors;anti-sense oligionucleotides and combinations thereof; cell cycleinhibitors, mTOR inhibitors, and growth factor receptor signaltransduction kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMGco-enzyme reductase inhibitors (statins); and protease inhibitors.

Transcatheter Delivery System

In an embodiment, with reference to FIG. 4A, a valve delivery system 500comprises a valve 100 having a collapsed configuration and an expandedconfiguration as previously described and an elongated flexible catheter480, such as a balloon catheter, configured to deploy the valve 100 viaendovascular access. The catheter 480 can comprise a balloon to expandthe valve 100 and/or if required, to touch up the valve 100 to ensureproper seating. The valve 100 can be mounted to the distal section ofthe catheter 480 for delivery through the vasculature. In order to holdthe valve in a collapsed configuration on the catheter 480, the valvedelivery system may further comprise a removable sheath (not shown) toclosely fit over the transcatheter valve 100.

A method of delivery can comprise the steps of radially compressing avalve into its collapsed configuration onto the distal end of anelongate flexible catheter having proximal and distal ends; deliveringthe valve to a tissue orifice, such as a native aortic valve orifice,via a transfemoral or transapical route, and expanding the valve intothe tissue orifice. The valve can be expanded by inflating a balloon.

A method of delivery can comprise the steps of radially compressing avalve into its collapsed configuration, onto the distal section of anelongated flexible catheter having proximal and distal ends. Arestraint, which can be connected to a tether that passes through theorifice of valve and the lumen of the catheter, is fitted around theposts of the valve. The valve is then delivered to a native valveorifice, such as a native aortic valve orifice, via a route of deliveryand expanded into the native orifice. The route of delivery can comprisea transfemoral or transapical route. The valve can be expanded byinflating a balloon.

Method of Making

Embodiments described herein also pertain to a method of making thevalve 100 embodiments as described herein. In order to make the variousembodiments, a cylindrical mandrel 710 can be used. With reference toFIG. 9A, the mandrel 710 comprises a structural form operable to receivethe leaflet frame 130 and outer frame 120 thereon.

With reference to FIGS. 9A-9B, an embodiment of a method of making avalve 100 comprises the steps of wrapping a first layer of film 160,e.g., a composite as described herein, into a tubular form about themandrel 710; placing the leaflet frame 130 and outer frame 120 over thefirst layer of film 160, as shown in FIG. 9A; forming a second layer offilm 160 over the leaflet frame 130 and the outer frame 120; thermallysetting the assembly; cutting the film 160 across the leaflet window topwithin the leaflet window 137, masking with release material 170 aportion of the film 160 in the leaflet window that defines the leaflet140 to prevent further bonding of leaflet 140 during subsequentprocessing steps; wrapping a second layer of film 160 into a tubularform over the leaflet frame 130, the outer frame 120, and over the firstlayer of film 160; thermal setting the assembly; remove the assemblyfrom the mandrel, telescopically insert the leaflet frame into the outerframe; placing the assembly back on the mandrel; thermal setting theassembly to couple the leaflet frame 130 to the outer frame 120 innesting engagement.

Embodiments described herein also pertain to a method of making thevalve 100 embodiments as described herein. In order to make the variousembodiments, a cylindrical mandrel 710 can be used. With reference toFIG. 12, the mandrel 710 comprises a structural form operable to receivethe leaflet frame 130 thereon. An embodiment of a method of making avalve 100 comprises the steps of wrapping a first layer of film 160,e.g., a composite as described herein, into a tubular form about themandrel 710; placing the leaflet frame 130 over the first layer of film160, as shown in FIG. 12; forming a second layer of film 160 over theleaflet frame 130; thermally setting the assembly; receiving theassembly over a cutting mandrel 712 as shown in FIGS. 13A and 13B;cutting the film 160 across the leaflet window top within the leafletwindow 137, resulting in the valve 100 of FIGS. 11A and 11B. In FIGS.11A and 11B the leaflets 140 are shown slightly open as held by thecutting mandrel 712. It is understood that a fully closed valve 100 willhave the free edges 142 of the leaflets 140 coming together to coaptunder the influence of downstream fluid pressure which results inclosing the valve to prevent downstream blood from flowing retrogradethrough the valve.

EXAMPLES Example 1

A heart valve was produced having polymeric leaflets formed from acomposite material having an expanded fluoropolymer membrane and anelastomeric material and joined between two collapsible metallic frames.

The leaflet frame and outer frame were laser machined from a length ofSS316LVM tube hard tempered with an outside diameter of 23.0 mm and awall thickness of 0.65 mm in the shape shown illustratively andgenerally indicated in FIG. 9A. The leaflet frame 130 and outer frame120 were electro-polished resulting in 0.0127 mm material removal fromeach surface and leaving the edges rounded.

Fluorinated ethylene propylene (FEP) powder (Daikin America, OrangeburgN.Y.) was then applied to the leaflet frame 130 and outer frame 120.More specifically, the FEP powder was stirred to form an airborne“cloud” in an enclosed blending apparatus, such as a standard kitchentype blender, while the frames were suspended in the cloud. The frameswere exposed to the FEP powder cloud until a uniform layer of powder wasadhered to the entire surface of the frames. The frames were thensubjected to a thermal treatment by placing it in a forced air oven setto 320° C. for approximately three minutes. This caused the powder tomelt and adhere as a thin coating over the entire frame. The frames wereremoved from the oven and left to cool to room temperature.

Initial Assembly and Thermal Process Cycle

A 21 mm diameter vented metal cylindrical mandrel having a diametercorresponding to the inner diameter of the leaflet frame 130 and outerframe 120 was helically wrapped with sintered ePTFE fiber. A thin filmof type 1 (ASTM D3368) FEP was constructed using melt extrusion andstretching. The type 1 (ASTM D3368) FEP film was about 40 pm thick andwas about 7.7 cm wide. The mandrel was helically wrapped with one layerof this type 1 FEP film over the sintered ePTFE fiber only in the regionof outer frame.

The mandrel was radially wrapped with five layers of an ePTFE membranewith an FEP coating towards the mandrel. The ePTFE membrane wasmanufactured according to the general teachings described in U.S. Pat.No. 7,306,729. The ePTFE membrane had a mass per area of 2.3 g/m², abubble point of 101.5 MPa, a thickness of about 356 nm, a matrix tensilestrength of 319 MPa in the longitudinal direction and 407 MPa in thetransverse direction.

The mandrel was helically wrapped with one layer of type 1 FEP film.

The diameter of the leaflet frame and outer frame were expanded slightlyand received on the wrapped mandrel with approximately a 10 mm spacebetween them, rotational alignment was not necessary.

The leaflet frame, outer frame and the space therebetween were helicallywrapped with 1 layer of type 1 FEP film.

The leaflet frame, outer frame and the space therebetween that willbecome the bridge portion 162, were circumferentially wrapped with 5layers of the same ePTFE membrane with an FEP coating as described abovewith the coating toward the mandrel.

The wrapped leaflet frame, outer frame and the space therebetween werewrapped with several layers of an ePTFE membrane imbibed with apolyimide material referred to as a release liner.

A substantially nonporous ePTFE membrane was configured into a cylinderand placed over the assembly, referred to as sacrificial tube. SinteredePTFE fiber was used to seal both ends of the sacrificial tube againstthe mandrel.

The assembly, including the mandrel, was heated in an oven capable ofapplying pneumatic pressure external to the sacrificial tube describedabove and while maintaining a vacuum internal to the mandrel for 40 minsuch that the mandrel temperature reached approximately 360° C. Theassembly was removed from the oven and allowed to cool to roomtemperature while still pressurized and under vacuum.

The sacrificial tube and release liner was removed. The sintered ePTFEfiber was removed to release the frame assembly from the mandrel.

The polymeric material was trimmed and removed from the leaflet windowsof the leaflet frame. The ends of each frame were circumferentiallytrimmed by a scalpel.

Intermediate Assembly and Thermal Process Cycle

An unsintered 15 mm diameter ePTFE tube was disposed on a 21.5 mm ventedmetal mandrel. Two layers of a substantially nonporous ePTFE membranewith a FEP coating was circumferentially wrapped on the mandrel with thecoating side towards the mandrel. The wrapped mandrel was placed in aconvection oven set to 320° C. and heated for 20 min. The ePTFE andsubstantially nonporous ePTFE membrane combined to serve as a releaseliner and was perforated to communicate pressure between the vent holesin the mandrel.

The leaflet frame was disposed onto the vented metal mandrel and ventholes were made in the apertures of the leaflet frame over the mandrelvent holes.

A leaflet material was then prepared. A membrane of ePTFE wasmanufactured according to the general teachings described in U.S. Pat.No. 7,306,729. The ePTFE membrane had a mass per area of 0.452 g/m², athickness of about 508 nm, a matrix tensile strength of 705 MPa in thelongitudinal direction and 385 MPa in the transverse direction. Thismembrane was imbibed with a fluoroelastomer. The copolymer consistsessentially of between about 65 and 70 weight percent perfluoromethylvinyl ether and complementally about 35 and 30 weight percenttetrafluoroethylene.

The fluoroelastomer was dissolved in Novec HFE7500 (3M, St Paul, Minn.)in a 2.5% concentration. The solution was coated using a Mayer bar ontothe ePTFE membrane (while being supported by a polypropylene releasefilm) and dried in a convection oven set to 145° C. for 30 seconds.After 2 coating steps, the final ePTFE/fluoroelastomer or composite hada mass per area of 1.75 g/m², 29.3% fluoropolymer by weight, a domeburst strength of about 8.6 KPa, and thickness of 0.81 μm.

The following test methods were used to characterize the ePTFE layersand the multi-layered composite. The thickness was measured with aMutitoyo Snap Gage Absolute, 12.7 mm (0.50″) diameter foot, ModelID-C112E, Serial # 10299, made in Japan. The density was determined by aweight/volume calculation using an Analytical Balance Mettler PM400 NewJersey, USA. The force to break and tensile strengths were measuredusing an Instron Model #5500R Norwood, Mass., load cell 50 kg, gagelength=25.4 cm, crosshead speed=25 mm/minute (strain rate=100% perminute) with flat faced jaws. Unless otherwise noted, these test methodswere used to generate the data in subsequent examples.

Ten layers of the composite leaflet material was wrapped around theleaflet frame with an elastomer rich side of the composite facingtowards the mandrel. In exemplary embodiments, the composite material isoriented to have a predetermined matrix tensile strength along adirection generally perpendicular with the longitudinal axis of thecombined tool assembly. More specifically, the predetermined matrixtensile strength is about 705 MPa.

The mandrel was radially wrapped with one layer of a substantiallynonporous ePTFE membrane with an FEP coating towards the mandrel with aspacing 8 mm from the base of the leaflet frame. The ePTFE membrane wasmanufactured according to the general teachings described in U.S. Pat.No. 7,306,729. The ePTFE membrane had a mass per area of about 11 g/m²,a thickness of about 5.5 μm, a matrix tensile strength of 310 MPa in thelongitudinal direction and 103 MPa in the transverse direction.

A Kapton® (EI DuPont de Nemours, Inc., Wilmington, Del.) polyimide filmacting as a mask was wrapped over the substantially nonporous ePTFEmembrane with an FEP coating layer.

The outer frame was placed on the mandrel with 10 mm spacing between theleaflet frame and the outer frame. The leaflet frame and the outer framewere aligned such that the longitudinal outer frame posts were collinearwith the leaflet frame posts.

The leaflet frame and outer frame were wrapped with 24 layers of thecomposite leaflet material described earlier with an elastomer rich sideof the composite facing towards the mandrel. In exemplary embodiments,the composite material is oriented to have a predetermined matrixtensile strength along a direction generally perpendicular with thelongitudinal axis of the combined tool assembly. More specifically, thepredetermined matrix tensile strength is about 705 MPa.

The final leaflet was comprised of 29.3% fluoropolymer by weight with athickness of approximately 27 μm. Each leaflet had 34 layers of thecomposite and a ratio of thickness/number of layers of 0.8 μm.

The mandrel was again radially wrapped with one layer of a substantiallynonporous ePTFE membrane with an FEP coating towards the mandrel with aspacing 8 mm from the base of the leaflet frame.

The assembly was wrapped with several layers of the sacrificial releaseliner. A sacrificial tube was placed over the assembly and sinteredePTFE fiber was used to seal both ends of the sacrificial tube againstthe mandrel.

The assembly was processed in an oven capable of applying pneumaticpressure external to the sacrificial material configured into a tubedescribed above and while maintaining a vacuum internal to the tube for25 min such that the mandrel temperature reached approximately 330° C.The assembly was removed from the oven and allowed to cool to roomtemperature while still pressurized and under vacuum.

The sacrificial tube and liner were removed from the frame assembly andthe frame assembly was removed from the mandrel. The Kapton® mask wasremoved.

A scalpel was used to circumferentially trim the free edge of eachleaflet and the distal end of leaflet frame.

Final Assembly and Thermal Process Cycle

The outer frame was radially expanded to a 24 mm diameter using atapered mandrel.

A release liner as described above was placed on a 21.5 mm ventedmandrel.

Three Kapton® masks were cut to the shape of leaflet window with a 30 mmtapered extension.

The frames with leaflet material were placed onto the mandrel and thetapered extensions of the Kapton® masks were inserted under the top ringof the leaflet frame from the trimmed end and were advanced axiallyuntil the masks aligned with the leaflet window.

The leaflet frame was wrapped with 2 layers of the type 1 FEP film.

A hot iron was used to remove the FEP film from the leaflet windowregion by melting it away from the perimeter and to tack the FEP film inall regions of leaflet frame outside the masks.

Vent holes were made within all the frame apertures and in the polymertube region connecting the inner and outer frame.

While holding the leaflet frame in place, the outer frame was coaxiallydisposed over the leaflet frame by telescopically inverting the bridgeportion of the contiguous tube.

The entire frame assembly was circumferentially wrapped with onesubstantially nonporous ePTFE membrane with an FEP coating towards themandrel.

The assembly was wrapped with several layers of the sacrificial releaseliner . A sacrificial tube was placed over the assembly and sinteredePTFE fiber was used to seal both ends of the sacrificial tube againstthe mandrel.

The assembly was processed in an oven capable of applying pneumaticpressure external to the sacrificial material configured into a tubedescribed above and while maintaining a vacuum internal to the tube for25 min such that the mandrel temperature reached approximately 330° C.The assembly was removed from the oven and allowed to cool to roomtemperature while still pressurized and under vacuum.

The frame assembly was removed from the mandrel.

A scalpel was used to circumferentially trim each end of leaflet frame.

The Kapton was rotationally peeled away from inside the outer frame andaway from leaflets.

Using scissors, both ends of the leaflet frame were trimmed to followframe contour.

The resulting valve 100 includes leaflets 140 formed from a compositematerial with more than one fluoropolymer layer having a plurality ofpores and an elastomer present in substantially all of the pores of themore than one fluoropolymer layer. Each leaflet 140 is movable between aclosed position, shown in FIGS. 3B, in which blood is substantiallyprevented from flowing through the valve assembly, and an open position,shown in FIG. 3A, in which blood is allowed to flow through the valveassembly. Thus, the leaflets 140 of the valve 100 cycle between theclosed and open positions generally to regulate blood flow direction ina human patient.

The performance of the valve leaflets was characterized on a real-timepulse duplicator that measured typical anatomical pressures and flowsacross the valve. The flow performance was characterized by thefollowing process:

The valve assembly was potted into a silicone annular ring (supportstructure) to allow the valve assembly to be subsequently evaluated in areal-time pulse duplicator. The potting process was performed accordingto the recommendations of the pulse duplicator manufacturer (ViVitroLaboratories Inc., Victoria BC, Canada)

The potted valve assembly was then placed into a real-time left heartflow pulse duplicator system. The flow pulse duplicator system includedthe following components supplied by VSI Vivitro Systems Inc., VictoriaBC, Canada: a Super Pump, Servo Power Amplifier Part Number SPA 3891; aSuper Pump Head, Part Number SPH 5891 B, 38.320 cm² cylinder area; avalve station/fixture; a Wave Form Generator, TriPack Part Number TP2001; a Sensor Interface, Part Number VB 2004; a Sensor AmplifierComponent, Part Number AM 9991; and a Square Wave Electro Magnetic FlowMeter, Carolina Medical Electronics Inc., East Bend, N.C., USA.

In general, the flow pulse duplicator system uses a fixed displacement,piston pump to produce a desired fluid flow through the valve undertest.

The heart flow pulse duplicator system was adjusted to produce thedesired flow (5 L/min), mean pressure (15 mmHg), and simulated pulserate (70 bpm). The valve under test was then cycled for about 5 to 20minutes.

Pressure and flow data were measured and collected during the testperiod, including right ventricular pressures, pulmonary pressures, flowrates, and pump piston position.

Parameters used to characterize the valve are effective orifice area andregurgitant fraction. The effective orifice area (EOA), which can becalculated as follows: EOA(cm²)=Q_(rms)/(51.6*(ΔP)^(1/2)) where Q_(rms)is the root mean square systolic/diastolic flow rate (cm³/s) and ΔP isthe mean systolic/diastolic pressure drop (mmHg).

Another measure of the hydrodynamic performance of a valve is theregurgitant fraction, which is the amount of fluid or blood regurgitatedthrough the valve divided by the stroke volume.

The hydrodynamic performance measured values were; EOA=2.06 cm², andregurgitant fraction=8.2%.

Example 2

Another valve was made as described in Example 1 with the followingexceptions.

Initial Assembly and Thermal Process Cycle

The diameter of the leaflet frame and outer frame were expanded slightlyand received on the wrapped mandrel with 16 mm space between them,rotational alignment if the leaflet frame and outer frame was made.

Final Assembly and Thermal Process Cycle

A scalpel was used to cut above the mechanical linking tab. The tab wasdeformed to link inner and outer frames.

The resulting valve 100 includes leaflets 140 formed from a compositematerial with more than one fluoropolymer layer having a plurality ofpores and an elastomer present in substantially all of the pores of themore than one fluoropolymer layer. Each leaflet 140 is movable between aclosed position, shown in FIG. 3B, in which blood is substantiallyprevented from flowing through the valve assembly, and an open position,shown in FIG. 3A, in which blood is allowed to flow through the valveassembly. Thus, the leaflets 140 of the valve 100 cycle between theclosed and open positions generally to regulate blood flow direction ina human patient.

The hydrodynamic performance was measured. The performance values were;EOA=2.3 cm² and regurgitant fraction=11.8%.

Numerous characteristics and advantages have been set forth in thepreceding description, including various alternatives together withdetails of the structure and function of the devices and/or methods. Thedisclosure is intended as illustrative only and as such is not intendedto be exhaustive. It will be evident to those skilled in the art thatvarious modifications can be made, especially in matters of structure,materials, elements, components, shape, size and arrangement of partsincluding combinations within the principles of the disclosure, to thefull extent indicated by the broad, general meaning of the terms inwhich the appended claims are expressed. To the extent that thesevarious modifications do not depart from the spirit and scope of theappended claims, they are intended to be encompassed therein.

What is claimed:
 1. A prosthetic valve comprising: a leaflet framehaving a generally tubular shape, the leaflet frame defining a pluralityof leaflet windows; an outer frame having a generally tubular shape; anda film, the leaflet frame being coaxially disposed at least partiallywithin the outer frame, the leaflet frame and outer frame being coupledat least in part by a contiguous portion of the film, at least a portionof the contiguous portion of the film being contained between andcoupling the leaflet frame and outer frame operable to prevent relativemovement and contact therebetween, wherein the film defines a leafletextending from each of the leaflet windows.
 2. The prosthetic valve ofclaim 1, wherein the film that defines the leaflet extends between theleaflet frame and the outer frame.
 3. The prosthetic valve of claim 1,wherein the leaflet has a base comprising a fold at an interface betweenportions of the film that are coupled with the leaflet frame andportions of the film that are not coupled with the leaflet frame.
 4. Theprosthetic valve of claim 1, wherein the film defines at least oneleaflet coupled to an outer surface of the leaflet frame, wherein thefilm defines a leaflet extending from each of the leaflet windows. 5.The prosthetic valve of claim 1, wherein the film defines at least oneleaflet coupled to an inner surface of the leaflet frame, wherein thefilm defines a leaflet extending from each of the leaflet windows. 6.The prosthetic valve of claim 1, wherein the film defines at least oneleaflet coupled to an inner surface and an outer surface of the leafletframe, wherein the film defines a leaflet extending from each of theleaflet windows.
 7. The prosthetic valve of claim 1, wherein the leafletframe defines three interconnected leaflet windows having asubstantially triangular shape.
 8. The prosthetic valve of claim 1,wherein each of the leaflet windows includes two leaflet window sides, aleaflet window base, and a leaflet window top.
 9. The prosthetic valveof claim 1, wherein a leaflet window side of one leaflet window isinterconnected with a leaflet window side of an adjacent leaflet window.10. The prosthetic valve of claim 1, wherein the leaflet window isdefined by window frame elements corresponding to leaflet sides andleaflet base, wherein the film is coupled to the window frame elementsand extends across the leaflet window defining the leaflet.
 11. Theprosthetic valve of claim 1, wherein the frame comprises a plurality ofspaced apart leaflet windows each defining substantially an isoscelestriangle interconnected by a base element, wherein each leaflet windowside is defined by a side of one triangle and a side of an adjacenttriangle, and wherein each leaflet window base is defined by the baseelement.
 12. The prosthetic valve of claim 1, wherein the prostheticvalve comprises a collapsed configuration and an expanded configurationfor transcatheter delivery.
 13. The prosthetic valve of claim 1, whereinthe leaflet is moveable between an open and closed position.
 14. Theprosthetic valve of claim 1, wherein the leaflet comprises a polymericmaterial.
 15. The prosthetic valve of claim 1, wherein the leafletcomprises a laminate.
 16. The prosthetic valve of claim 15, wherein thelaminate has more than one layer of a fluoropolymer membrane.
 17. Theprosthetic valve of claim 1, wherein the leaflet comprises a film havingat least one fluoropolymer membrane layer having a plurality of poresand an elastomer present in substantially all of the pores of at leastone layer of fluoropolymer membrane.
 18. The prosthetic valve of claim17, wherein the film comprises less than about 80% fluoropolymermembrane by weight.
 19. The prosthetic valve of claim 17, wherein theelastomer comprises (per)fluoroalkylvinylethers (PAVE).
 20. Theprosthetic valve of claim 17, wherein the elastomer comprises acopolymer of tetrafluoroethylene and perfluoromethyl vinyl ether. 21.The prosthetic valve of claim 17, wherein the fluoropolymer membranecomprises ePTFE.
 22. The prosthetic valve of claim 1, wherein either orboth of the leaflet frame and outer frame defines a generally openpattern of apertures operable to allow the outer frame to be compressedand expanded between different diameters.
 23. The prosthetic valve ofclaim 1, wherein either or both of the leaflet frame and outer framecomprise a shape memory material.
 24. The prosthetic valve of claim 1,wherein the outer frame includes frame elements that overlay the leafletwindows that are defined by the leaflet frame in cooperative arrangementso as to provide structural support over the leaflet windows.
 25. Aprosthetic valve comprising: a leaflet frame having a generally tubularshape, the leaflet frame defining a plurality of leaflet windows; anouter frame having a generally tubular shape; and a film, the leafletframe being coaxially disposed at least partially within the outerframe, wherein the outer frame includes frame elements that overlayleaflet windows that are defined by the leaflet frame in cooperativearrangement so as to provide structural support over the leafletwindows, wherein the film defines a leaflet extending from each of theleaflet windows.
 26. The prosthetic valve of claim 25, wherein the filmis disposed between the leaflet frame and the outer frame.
 27. Theprosthetic valve of claim 25, wherein the leaflet frame and outer frameare separated by the film and are not in contact with each other. 28.The prosthetic valve of claim 25, wherein the film that defines theleaflet extends between the leaflet frame and the outer frame.
 29. Theprosthetic valve of claim 25, wherein the leaflet has a base comprisinga fold at an interface between portions of the film that are coupledwith the leaflet frame and portions of the film that are not coupledwith the leaflet frame.
 30. The prosthetic valve of claim 25, whereinthe film defines at least one leaflet coupled to an outer surface of theleaflet frame, wherein the film defines a leaflet extending from each ofthe leaflet windows.
 31. The prosthetic valve of claim 25, wherein thefilm defines at least one leaflet coupled to an inner surface of theleaflet frame, wherein the film defines a leaflet extending from each ofthe leaflet windows.
 32. The prosthetic valve of claim 25, wherein thefilm defines at least one leaflet coupled to an inner surface and anouter surface of the leaflet frame, wherein the film defines a leafletextending from each of the leaflet windows.
 33. The prosthetic valve ofclaim 25, wherein the leaflet frame defines three interconnected leafletwindows having a substantially triangular shape.
 34. The prostheticvalve of claim 25, wherein each of the leaflet windows includes twoleaflet window sides, a leaflet window base, and a leaflet window top.35. The prosthetic valve of claim 25, wherein a leaflet window side ofone leaflet window is interconnected with a leaflet window side of anadjacent leaflet window.
 36. The prosthetic valve of claim 25, whereinthe leaflet window is defined by window frame elements corresponding toleaflet sides and leaflet base, wherein the film is coupled to thewindow frame elements and extends across the leaflet window defining theleaflet.
 37. The prosthetic valve of claim 25, wherein the framecomprises a plurality of spaced apart leaflet windows each definingsubstantially an isosceles triangle interconnected by a base element,wherein each leaflet window side is defined by a side of one triangleand a side of an adjacent triangle, and wherein each leaflet window baseis defined by the base element.
 38. The prosthetic valve of claim 25,wherein the prosthetic valve comprises a collapsed configuration and anexpanded configuration for transcatheter delivery.
 39. The prostheticvalve of claim 25, wherein the leaflet is moveable between an open andclosed position.
 40. The prosthetic valve of claim 25, wherein theleaflet comprises a polymeric material.
 41. The prosthetic valve ofclaim 25, wherein the leaflet comprises a laminate.
 42. The prostheticvalve of claim 41, wherein the laminate has more than one layer of afluoropolymer membrane.
 43. The prosthetic valve of claim 25, whereinthe leaflet comprises a film having at least one fluoropolymer membranelayer having a plurality of pores and an elastomer present insubstantially all of the pores of at least one layer of fluoropolymermembrane.
 44. The prosthetic valve of claim 43, wherein the filmcomprises less than about 80% fluoropolymer membrane by weight.
 45. Theprosthetic valve of claim 43, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).
 46. The prosthetic valve of claim 43,wherein the elastomer comprises a copolymer of tetrafluoroethylene andperfluoromethyl vinyl ether.
 47. The prosthetic valve of claim 43,wherein the fluoropolymer membrane comprises ePTFE.
 48. The prostheticvalve of claim 25, wherein either or both of the leaflet frame and outerframe defines a generally open pattern of apertures operable to allowthe outer frame to be compressed and expanded between differentdiameters.
 49. The prosthetic valve of claim 25, wherein either or bothof the leaflet frame and outer frame comprise a shape memory material.50. A method of making a valve, comprising: wrapping a first layer of afilm into a tubular form about a mandrel; providing a leaflet framehaving a generally tubular shape, the leaflet frame having a leafletframe inner surface and a leaflet frame outer surface, the leaflet framedefining a plurality of leaflet windows having a window top; providingan outer frame having a generally tubular shape, the outer frame havingan outer frame inner surface and an outer frame outer surface; placingthe leaflet frame and the outer frame over the first layer of film withthe leaflet frame and outer frame spaced apart from each other defininga bridge portion therebetween, the leaflet frame inner surface and theouter frame inner surface in contact with the first layer of film;forming a second layer of film over the leaflet frame and the outerframe in contact with the leaflet frame outer surface and the outerframe outer surface; coupling the first layer of film and the secondlayer of film to each other and to the leaflet frame and the outerframe; cutting the first layer of film and the second layer of filmacross the window top within the leaflet window so as to define aleaflet free edge; masking with release material a portion of the filmdisposed in the leaflet window that defines the leaflet to preventfurther bonding of the leaflet during subsequent processing steps;wrapping a third layer of film into a tubular form over the second layerof film and over the release material that is over the leaflet window,overlapping the leaflet frame, the outer frame, and over the bridgeportion between the leaflet frame and outer frame; coupling the thirdlayer of film and the second layer of film to each other forming anassembly; removing the assembly from the mandrel; disposing coaxiallyand at least partially the leaflet frame into the outer frame, foldingand overlapping at least partially the bridge portion so as to containthe bridge portion between the leaflet frame and the outer frame;placing the assembly back on the mandrel; and coupling the bridgeportion to itself and to the third layer of film adjacent the leafletframe outer surface and the first layer adjacent the outer frame innersurface in nesting engagement.
 51. A method of making a prostheticvalve, comprising: wrapping a first layer of film into a tubular formabout a mandrel; providing a leaflet frame having a generally tubularshape, the leaflet frame having a leaflet frame inner surface and aleaflet frame outer surface, the leaflet frame defining a plurality ofleaflet windows having a window top; placing the leaflet frame over thefirst layer of film, the leaflet frame inner surface in contact with thefirst layer of film; forming a second layer of film over the leafletframe in contact with the leaflet frame outer surface; coupling thefirst layer of film and the second layer of film to each other and tothe leaflet frame.